Elixir Department: SOP for Cleaning After Batch Failure – V 2.0

Standard Operating Procedure for Cleaning After Batch Failure in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/186/2025
Supersedes	SOP/ELX/186/2022
Page No.	Page 1 of 10
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To outline a comprehensive and risk-controlled procedure for cleaning of equipment, areas, and accessories following a batch failure during elixir manufacturing, ensuring complete removal of residues and preventing cross-contamination.

2. Scope

This SOP applies to all equipment, utensils, pipelines, and related surfaces used during failed or rejected batches of elixirs in the Elixir Manufacturing Department.

3. Responsibilities

Production Operator:
- Perform initial segregation and cleaning activities post-failure.
Production Supervisor:
- Initiate cleaning protocol and inform QA and Engineering.
QA Officer:
- Verify cleaning effectiveness and approve equipment for reuse.
Engineering Department:
- Support equipment disassembly and cleaning in case of residue adherence or operational issues.

4. Accountability

The Production Head is accountable for executing the cleaning process after batch failure. QA Head is responsible for verification, compliance, and documentation of the entire process.

5. Procedure

5.1 Initiation

Immediately inform

QA, Engineering, and Production Head upon confirmation of batch failure.

Segregate the failed batch material and transfer to a designated area with “REJECTED – HOLD FOR DISPOSAL” label.

Quarantine the equipment used until cleaning is completed and verified.

5.2 Risk Assessment

QA to perform a risk assessment based on:
- Nature of failure (e.g., microbial contamination, physical non-conformity, chemical incompatibility)
- Solubility and stickiness of the product
- Contamination potential
Determine whether routine or intensified cleaning is required.

5.3 Cleaning Execution

Drain all process lines and rinse with purified water to remove bulk residue.
Apply 1–2% validated detergent solution and manually scrub product-contact surfaces.
Perform multiple rinses with purified water until rinse water meets conductivity/pH acceptance criteria.
If product was alcohol-based, use appropriate solvent flush or hot water as per cleaning validation.
Inspect and clean auxiliary parts like valves, nozzles, gaskets, and transfer pipes.

5.4 Verification and Documentation

QA to visually inspect for residual material, stains, or odor.
If required, collect swab or rinse samples for analytical testing as per validation protocol.
Document cleaning activity in the Batch Failure Cleaning Logbook (Annexure-1).
Equipment to be marked as “CLEANED – READY FOR USE” only after QA approval.

5.5 Reassembly and Clearance

Engineering to support reassembly of any disassembled parts.
Conduct air drying or hot air cabinet drying as per SOP/ELX/185/2025.
Final clearance given by QA to Production before use in subsequent batch.

6. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance
CIP: Clean-In-Place

7. Documents

Batch Failure Cleaning Logbook (Annexure-1)
Cleaning Verification Report
Deviation/Non-Conformance Report

8. References

21 CFR Part 211.67 – Equipment Cleaning and Maintenance
ICH Q7 – GMP for Active Pharmaceutical Ingredients
WHO TRS 986 – GMP Annex 4: Cleaning Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Failure Cleaning Logbook

Date	Batch No.	Equipment ID	Cleaning Performed By	QA Verified By	Remarks
11/04/2025	ELX-0425-007	MXR-ELX-06	Rajesh Kumar	Sunita Reddy	Visually Cleaned – Swab Results Pending

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Release	New SOP	QA Head
11/04/2025	2.0	Added risk assessment and sampling clause	Regulatory Compliance	QA Head